Weaning Form Mechanical Ventilation Using Extracorporeal CO2 Removal

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2016
• Main ID: NCT02259335
• Date of registration: 04/10/2014
• Prospective Registration: No
• Primary sponsor: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Public title: Weaning Form Mechanical Ventilation Using Extracorporeal CO2 Removal WeanPRO
• Scientific title: A Pilot Study on the Use of Extracorporeal CO2 Removal During the Weaning Process From Mechanical Ventilation
• Date of first enrolment: October 2014
• Target sample size: 15
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02259335
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Italy

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients meeting the criteria for readiness to be weaned (i.e. clinical stability,
FiO2<50%, normal sensorium, body temperature < 38 and satisfactory cough reflex)

- Failing a T-piece trial after 1 hour or before for a rise in PaCO2>20% from baseline
and with f/VT ratio >100

Exclusion Criteria:

- Patients NOT meeting the criteria for readiness to be weaned

- Patients succeeding a T-piece trial



Age minimum: 18 Years
Age maximum: 90 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Patients With Acute Hypercapnic Respiratory Failure

Intervention(s)

Device: Extracorporeal CO2 removal device

Primary Outcome(s)

weaning success [Time Frame: 48 hours]

passing a weaning trial using a T-piece method [Time Frame: 1 hour]

Secondary Outcome(s)

Physiological variables (i.e. Arterial Blood Gases, vitals and dyspnea) [Time Frame: 48 hours]

Secondary ID(s)

110/2014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Turin, Italy